Comparison of Educational Methods for Teaching Peripheral Blood Smears (PBS)

March 27, 2023 updated by: Anthony A. Donato, The Reading Hospital and Medical Center

A Randomized, Controlled Cross Over Trial of Two Educational Methods and Their Additive Effects in the Recognition of Abnormal Peripheral Blood Smears

This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

General Approach:

This study will employ a randomized, controlled design and will use as its outcomes two separate post-tests, one after the first teaching session and one 4 weeks after the second intervention.

Design The investigators are attempting to find whether the combination of basic science education using an 1-hour additive microskills- building method along with compare/ contrast model versus a 1-hour traditional case-based format would improve performance on a visual recognition test of hematology questions. A final test at 4 weeks after the cross-over between the two groups will also help investigators analyze whether the order of exposure to the teaching method would have an impact on the final performance.

Sampling, including sample size and statistical power:

Sample size will be between 40-50 resident physicians meeting inclusion criteria for the study. There is not enough data in the literature to effectively determine power, so we will use a convenience sample of the largest feasible group (around 40).

Collection of data:

Data will be collected on an excel spreadsheet and will be permanently de-identified on that spreadsheet; it will be kept on a password-protected site.

Information management and analysis software:

Data will be entered into a password protected excel spreadsheet and each study participant will be assigned a unique identifier code which will be used to link the data. Statistical analysis will be performed using SPSS version 20.

Data entry, editing and management, including handling of data collection forms, different versions of data, and data storage and disposition:

Paper surveys and tests will be collected, recorded and locked; they will be destroyed 2 years after termination of the study. A paired t-test will be used to compare the two samples means for significance.

Quality Control / Assurance:

Pretest and post-tests will be checked against a gold standard, a hospital board-certified hematopathologist, to check the quality of the slides.

Bias in data collection, measurement and analysis:

Given the small numbers of participants expected, a Type 1 error (failure to detect a difference in groups when one exists) is possible, as the study will possibly be underpowered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19612
        • Reading Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Internal medicine and Family Medicine residents and faculty at The Reading Hospital and Medical Center having completed medical school

Exclusion Criteria:

  • Practicing/ board certified hematologists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
Group 1 will receive 1 hour of compare-contrast basic science teaching of cell recognition to enhance recognition of those photographs, followed by 1 hour Case vignette-based teaching of cell recognition 2 weeks later
Other: Case vignette-based teaching of cell recognition
Intervention group members will be taught peripheral blood smears by using power point slides and utilizing additive microskills using the compare/ contrast technique to recognize various cell types. Memory will be reinforced by using cases to help recognize the clinical importance of learning about individual cell types.
Other: Compare-contrast basic science teaching of cell recognition
The control group will be given a traditional 60-minute lecture using board review questions with accompanying pictures of peripheral blood smears, without explaining individual cell type.
Active Comparator: Group 2
Group 2 will receive 1 hour of Case vignette-based teaching of cell recognition followed by compare-contrast basic science teaching of cell recognition 2 weeks later
Other: Case vignette-based teaching of cell recognition
Intervention group members will be taught peripheral blood smears by using power point slides and utilizing additive microskills using the compare/ contrast technique to recognize various cell types. Memory will be reinforced by using cases to help recognize the clinical importance of learning about individual cell types.
Other: Compare-contrast basic science teaching of cell recognition
The control group will be given a traditional 60-minute lecture using board review questions with accompanying pictures of peripheral blood smears, without explaining individual cell type.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in post test scores at 2 and 4 weeks after education
Time Frame: 4 weeks
Primary outcome was an improvement in test score from pre-test to 2 and 4-week post-test. All participants took a 15-question pretest in addition to a posttest at 2 and 4 weeks. Each test consisted of pictures of various cell types from the peripheral blood.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Reading Hospital and Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anthony Donato, MD, The Reading Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRHMC 016-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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